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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: Sept. 30, 2016

Posted today in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: Pregnant Women Should Delay Travel to 11 Southeast Asian Countries: CDC Pregnant women should consider delaying nonessential travel to 11 Southeast Asian countries where the Zika virus is circulating, the U.S. Centers for Disease Control and Prevention advises. The countries covered by the advisory include Brunei,...

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1 in 10 Stroke Rehab Interruptions May Be Preventable

Posted today in Medical

FRIDAY, Sept. 30, 2016 -- Interruptions in inpatient rehabilitation occur for some stroke survivors and patients with brain and spinal cord injuries, a new study finds. But at least one-tenth of these treatment breaks could be prevented, resulting in improved patient outcomes and lower health care costs, the researchers said. The findings indicate that inpatient rehabilitation facilities "are performing well in...

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Hormone Therapy for Prostate Cancer Less Safe for Men With Prior Heart Attack

Posted today in Medical

FRIDAY, Sept. 30, 2016 -- Men diagnosed with prostate cancer often receive hormone-depleting therapy to help fight the tumor. But a new study suggests that the treatment may pose a risk to men who've previously suffered a heart attack. "Patient age, cardiac risk, and disease recurrence risk should be considered when selecting candidates for hormone therapy in this patient population," lead researcher Dr. Nataniel...

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It May Be Time to Punt on Your Favorite Football Fare

Posted today in Medical

FRIDAY, Sept. 30, 2016 -- Fried foods and free-flowing beer may be the norm at many football or tailgate parties, but the American Heart Association (AHA) says there are many healthier options. When it comes to meats for the grill, they recommend choosing lean or extra-lean beef burgers and keeping the patties to the size of a deck of cards. Or try turkey or salmon burgers. Instead of fried chicken wings, grill...

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CDC: Pregnant Women Should Avoid Southeast Asia Due to Zika

Posted today in Medical

FRIDAY, Sept. 30, 2016 -- Zika continues to extend its reach around the globe, with U.S. health officials now urging women to delay travel to 11 countries in Southeast Asia where the virus is circulating. Reports are also describing the first two cases of Zika-linked microcephaly in Thailand. Since the Zika outbreak began last year, thousands of babies, mostly in Brazil, have been born with the devastating brain...

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Monthly News Roundup - September 2016

Posted yesterday in Pharma Industry News

Amjevita, a Biosimilar to Humira, Wins FDA Approval Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and plaque psoriasis. Amjevita is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ...

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FDA Approves Orkambi (lumacaftor/ivacaftor) for Use in Children with Cystic Fibrosis Ages 6 through 11 who have Two Copies of the F508del Mutation

Posted 3 days ago in New Drug Approvals

BOSTON--(BUSINESS WIRE) September 28, 2016 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved Orkambi (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation. People with this mutation represent the largest population of those with CF, a rare, life-threatening...

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Pain Therapeutics Receives Complete Response Letter for Remoxy ER

Posted 4 days ago in New Drug Applications

AUSTIN, Texas, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for Remoxy ER (oxycodone capsules CII). The CRL informs that Remoxy ER cannot be approved in its present form and specifies additional actions and data that...

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FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease

Posted 5 days ago in New Drug Approvals

HORSHAM, Pa., Sept. 26, 2016 /PRNewswire/ -- Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF)...

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Biogen Completes Rolling Submission of New Drug Application to FDA for Nusinersen as a Treatment for Spinal Muscular Atrophy

Posted 5 days ago in New Drug Applications

CAMBRIDGE, Mass. & CARLSBAD, Calif.--(BUSINESS WIRE) September 26, 2016 --Biogen (NASDAQ: BIIB) and Ionis (NASDAQ:IONS) today announced that Biogen has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of nusinersen, an investigational treatment for spinal muscular atrophy (SMA). Biogen has also applied for Priority Review which, if...

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U.S. FDA Approves Labeling Update of Rexulti (brexpiprazole) for Maintenance Treatment of Schizophrenia

Posted 7 days ago in New Drug Approvals

Princeton, New Jersey and Valby, Denmark – September 23, 2016 – Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved the labeling update of Rexulti (brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia. The approval was based on results from a long-term randomized ...

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Janssen Submits Application Seeking Approval of Sirukumab in United States for Rheumatoid Arthritis

Posted 7 days ago in New Drug Applications

HORSHAM, Pa.--(BUSINESS WIRE) September 23, 2016 --Janssen Biotech, Inc. (Janssen) announced today the submission of a Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). RA is a chronic, systemic inflammatory condition that affects...

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FDA Approves Expanded Indications for Ilaris (canakinumab) for Three Rare Periodic Fever Syndromes

Posted 7 days ago in New Drug Approvals

September 23, 2016 -- The U.S. Food and Drug Administration today approved three new indications for Ilaris (canakinumab). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients: Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS); Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD); and Familial Mediterranean Fever (FMF). All...

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FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 8 days ago in New Drug Approvals

September 23, 2016 -- The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to...

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Newron Re-Submits US NDA for Xadago (safinamide)

Posted 9 days ago in New Drug Applications

MILAN--(BUSINESS WIRE) September 22, 2016 --Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain, and its partners Zambon S.p.A. and US WorldMeds, LLC, announced today that Newron has re-submitted the New Drug Application (NDA) for Xadago®(safinamide) to the US Food and Dr...

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Puma Biotechnology Announces FDA Acceptance of NDA for PB272 (Neratinib) for Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

Posted 11 days ago in New Drug Applications

LOS ANGELES, Calif., Sept. 20, 2016 - Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant...

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Monthly News Roundup - August 2016

Posted 4 weeks ago in Pharma Industry News

FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel A third U.S. biosimilar has been FDA-approved; this time it’s Erelzi (etanercept-szzs), a biosimilar to Amgen’s tumor necrosis factor (TNF) blocker Enbrel. Sandoz’s Erelzi is the first approved biosimilar for etanercept, and is used for the same five indications found on the reference product Enbrel: rheumatoid arthritis, polyarticular juvenile idiopathic arthrit...

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FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu

Posted 8 weeks ago in Pharma Industry News

On August 3, 2016, the U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999. The FDA is committed to...

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Kratom Seized in California by US Marshals Service

Posted 8 weeks ago in Pharma Industry News

August 4, 2016 -- The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately...

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Monthly News Roundup - July 2016

Posted 8 weeks ago in Pharma Industry News

Injectable Adlyxin FDA-Approved for Type 2 Diabetes The FDA has approved Sanofi’s Adlyxin (lixisenatide), a new once-daily injectable type 2 diabetes medication. Adlyxin is classified as an incretin mimetic/GLP-1 receptor agonist. For maintenance dosing, Adlyxin will be available in a disposable pre-filled pen of 20 micrograms. Adlyxin is given at mealtime and used alongside diet and exercise to improve blood s...

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Summit Receives Fast Track Designation From US FDA for Ezutromid in the Treatment of Duchenne Muscular Dystrophy

Posted 5 days ago in Clinical Trials

OXFORD, United Kingdom, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, today announces it has received Fast Track designation from the US Food and Drug Administration (‘FDA’) for ezutromid in the treatment of DMD. Ezutromid is a utrophin modu...

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Gilead Terminates Phase 2/3 Study of GS-5745 in Patients With Ulcerative Colitis

Posted 9 days ago in Clinical Trials

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 21, 2016-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company is stopping its combined Phase 2/3 clinical study of GS-5745, an investigational anti-MMP9 antibody, among patients with moderately to severely active ulcerative colitis. This decision follows a planned interim analysis of unblinded efficacy and safety data by the Data Monitoring Committee (DMC)...

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Novel Novartis malaria compound shows potential to be effective against infections resistant to all currently available antimalarial drugs

Posted 9 days ago in Clinical Trials

Basel, September 21, 2016 - Today Novartis published proof of concept study results in the New England Journal of Medicine showing that its new antimalarial compound, KAF156, demonstrated activity against both vivax and falciparum malaria, including artemisinin-resistant parasites. Malaria is a life-threatening disease primarily caused by parasites (Plasmodium falciparum and Plasmodium vivax) transmitted to...

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Vical and Astellas Announce Topline Results from a Phase 2 Study of Investigational Cytomegalovirus (CMV) Vaccine (ASP0113) in Kidney Transplant Patients

Posted 12 days ago in Clinical Trials

SAN DIEGO and TOKYO - September 19, 2016 – Vical Incorporated (Nasdaq: VICL) and Astellas Pharma Inc. (TOKYO: 4503) today announced topline results from a randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety and efficacy of cytomegalovirus (CMV) vaccine, ASP0113, versus placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor. Results from the study d...

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Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis

Posted 12 days ago in Clinical Trials

THOUSAND OAKS, Calif. and BRUSSELS, Sept. 18, 2016 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced findings from the FRAME study showing that the investigational agent romosozumab significantly reduced the incidence of new vertebral fractures in postmenopausal women with osteoporosis through 12 and 24 months, meeting the study's co-primary endpoints. The results from the Phase 3...

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